Manufacturing Site Change Country of Origin

1. Key takeaways

The 2024 amending decree (internal number MS-AJ-CB-200-2024) rewrote Article 18.11.4 of RTCR 505:2022 in its first article: where a change of manufacturing site or address (domestic or abroad, including subsidiaries) results in a change of country of origin, and the new country of origin is not covered by mutual recognition of registration system equivalence, the applicant must complete the full documentation set for its class — Article 11 for Clase 2 IVD, Article 12 for Clase 3, Article 13 for Clase 4. The old Article 18.11.4 said only that missing dossier items must be completed; the new version anchors the exact articles, narrowing the room for discretion. The GRZAN regulatory team’s assessment: this is the provision in the 2024 amendment most likely to be underestimated, because it turns a change that looks like merely moving factories into a substantively fresh application.

• The trigger is a three-element test: site change, resulting change of country of origin, and no equivalence recognition for the new country.
• The new wording converts dossier completion from a concept into a checklist tied to Articles 11, 12 and 13 by class.
• The 2024 Article 17.3 closes the same loop from the other side, for equivalence-based registrations whose CLV is later issued by a non-recognised authority.
• Article 18.16.6 imposes the same duty in the double-change scenario of holder and manufacturer changing together.
• The BPM certificate item is deferred under Transitorio I, but revives once the national BPM regulation issues.

2. Legal basis

The completion obligation is created by the 2024 amendment and operates inside the change regime of RTCR 505:2022.

3. Expert insights

Insight one: The trigger is a three-element test; if any element is missing, it does not trigger. The elements of the new Article 18.11.4 are: first, a change of manufacturing site or address (domestic or abroad, including subsidiaries); second, that change results in a change of country of origin; and third, the new country is not covered by mutual recognition of registration system equivalence (acuerdo de equivalencia del sistema de registro). Only when all three hold must the dossier be completed. If the new country is already recognised, or the address change does not change the country of origin, only the routine documents of 18.11.1 to 18.11.6 apply.

Insight two: The new version turns completion from a concept into a checklist. The old Article 18.11.4 read debe presentar todos los requisitos faltantes para completar el expediente de acuerdo a su clase; the new version reads debe presentar los requisitos establecidos en el artículo 1º numeral 11 para los EMB clase 2 de diagnóstico in vitro, artículo 1° numeral 12 para los EMB clase 3 y en el artículo 1º numeral 13 para los EMB clase 4. The meaning shifts from completing whatever is missing to submitting the full set by class: the reviewer’s discretion narrows, and the documentation a company must prepare rises markedly.

Insight three: The 2024 Article 17.3 forms a closed loop with the same logic. The new 17.3 provides that for registrations relying on equivalence recognition, once the CLV submitted is issued by the authority of a non-recognised country, the missing documentation must be completed. Article 18.11.4 handles the site-change scenario; Article 17.3 handles the change-of-CLV-issuing-country scenario. Together they point to one policy goal: the equivalence relief must not become a channel for bypassing full review.

Insight four: Article 18.16.6 is the double-change version. Where holder and manufacturer change at the same time (Article 18.16) and the change results in a change of country of origin without recognition, Article 18.16.6 imposes the same completion duty; it uses the wording reconocimiento del sistema de registro — different from the acuerdo de equivalencia wording of 18.11.4 but the same mechanism. Mergers, restructurings and brand transfers should check both provisions.

Insight five: The BPM item is deferred, but the provision stands. Article 18.11.1 requires the BPM certificate under Article 11.5, yet Transitorio I of the approving decree states that the BPM certificates of Articles 11.5, 16.5, 18.9.2, 18.11.1 and 18.16.3 are not mandatory before the national BPM regulation is issued; Transitorio IV requires the Ministry of Health to issue it within 12 months of entry into force. The GRZAN regulatory team notes: deferral is not deletion. Once the BPM regulation is published, the obligation revives immediately, and capacity planning should assume it will.

4. Practical recommendations

• Treat a factory move as a major change project: determine in writing whether the country of origin changes and whether the new country is covered by recognition, rather than relying on experience.
• Where possible, keep the recognition path: if the group has capacity in several countries, prefer a new site in a country covered by equivalence recognition, avoiding the completion obligation of 18.11.4 altogether.
• Where there is no recognition, prepare to first-registration standards: the full Article 11 set for Clase 2 IVD, Article 12 for Clase 3 and Article 13 for Clase 4, not a lighter change-scale timeline.
• Handle the CLV and the new labels in parallel: Article 18.11.2 requires a new CLV for imported products and Article 18.11.5 requires new labels where the country of origin changes; under the 2024 Article 4.7 the CLV may be issued by the authority of the holder’s country, the holder’s subsidiary’s country or the parent company’s subsidiary’s country, but the subsidiary must be legally established there.
• Leave an interface for BPM: even under the deferral, obtain the target factory’s quality system certificate at the time of the move, avoiding a second submission after publication.
• Check both provisions in merger and brand-transfer projects: where holder and manufacturer change together, verify Articles 18.11.4 and 18.16.6 and file as a whole under Article 18.16.

5. Verification checklist

• □ Whether the new site changes the country of origin has been confirmed (written determination)
• □ Whether the new country is covered by equivalence recognition has been confirmed (written determination)
• □ Without recognition, the full set for the class is ready under Articles 11, 12 or 13
• □ A valid CLV for the new site (imports, Article 18.11.2) or an operating permit (domestic products) has been obtained
• □ The Article 11.8 manufacturing contract is ready for third-party manufacturing (Article 18.11.3)
• □ New labels under Article 11.7 are ready where the country of origin changes (Article 18.11.5)
• □ The BPM certificate handling during the Transitorio I deferral has been assessed and an interface reserved
• □ Merger projects have checked Article 18.16.6 and filed as a whole under Article 18.16
• □ The payment voucher at the official rate is ready (Article 18.11.6)

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for the Costa Rican market. Our team manages Ministry of Health (Ministerio de Salud) sanitary registration applications, prepares Spanish-language dossiers, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com